Qoo0909 2010-4-14 15:22
FDA核准Pramipexole緩釋劑型用於後期巴金森氏症
作者：Susan Jeffrey
出處：WebMD醫學新聞
March 25, 2010 — 該公司發佈，美國食品藥物管理局（FDA）已經核准一天使用一次的Pramipexole（Mirapex，百靈佳殷格爾藥廠）用於治療後期巴金森氏症（PD）。
這項新的核准案類似FDA於2010年2月核准使用pramipexole緩釋錠用於治療早期PD。
根據百靈佳殷格爾藥廠的聲明，於後期病患身上使用緩釋劑型由一項隨機分派、雙盲研究資料支持，這項研究共有517位病患被隨機分派接受不同劑量一天一次緩釋劑型的pramipexole，或每天三次的立即釋放型、或安慰劑。
百靈佳殷格爾藥廠在聲明中表示，試驗的主要終點是18週時單元巴金森氏疾病評比指標第2與第3部份校正後平均差異；第2部份的分數以症狀出現與消退的平均值取得，第3部份的分數由症狀發生時間評估。
18週的治療後，緩釋與立即釋放型pramipexole比安慰劑好，不論是主要或次要終點，在第33週時，相較於安慰劑也有比較好的表現。聲明稿中表示，緩釋與立即釋放型的pramipexole相較於安慰劑的結果是相當的。
對後期AD且同時接受levodopa治療病患，最常見的不良反應，發生率超過5%的包括運動困難、噁心、便秘、幻覺、頭痛與食慾不振。
英國倫敦學院大學神經學機構的臨床神經學專家部門主任與主席Anthony Schapira醫師在百靈佳殷格爾藥廠的新聞稿中表示，隨著這項核准案，緩釋劑型現在可能可以早期協助這些病患，且讓後期PD患者有更方便一天給藥一次的時程。
FDA Approves Pramipexole Extended Release for Advanced Parkinson's
By Susan Jeffrey
Medscape Medical News
March 25, 2010 — The US Food and Drug Administration (FDA) has approved the use of once-daily pramipexole (Mirapex, Boehringer Ingelheim Pharmaceuticals) for use in advanced Parkinson's disease (PD), the company has announced.
The new approval comes after a similar FDA approval in February 2010 for the use of pramipexole extended-release tablets in early PD.
Use of the extended-release formulation in advanced patients was supported by data from 1 randomized, double-blind controlled trial, according to a statement from Boehringer-Ingelheim. A total of 517 patients were randomly assigned to varying doses of once-daily extended-release pramipexole, immediate-release pramipexole taken 3 times daily, or placebo.
The primary endpoint was adjusted mean change at week 18 in the United Parkinson's Disease Rating Scale parts 2 and 3; the score for part 2 was averaged for on and off time, and part 3 was assessed during on time, the Boehringer-Ingelheim statement notes.
Both extended- and immediate-release pramipexole were superior to placebo after 18 weeks of treatment on both the primary and secondary endpoints, including change in daily off time at week 18. Maintenance of efficacy was also seen at week 33 vs placebo. Results were similar with both the extended- and immediate-release formulations of pramipexole vs placebo, the statement said.
The most common adverse events, those with an incidence of more than 5%, and greater than placebo in those with advanced PD who were treated concomitantly with levodopa, were dyskinesia, nausea, constipation, hallucinations, headache, and anorexia.
With this approval, the extended-release formulation "may now help early as well as advanced PD patients with its convenient once-daily dosing schedule," said Anthony Schapira, MD, head of department and chairman of Clinical Neurosciences Specialties at the Institute of Neurology, University College London, United Kingdom, in the Boehringer-Ingelheim release.